This collaboration underscores CliniOps' continued mission to transform clinical research through smart technologies, enabling equitable access, operational efficiency, and robust data quality, even in hard-to-reach geographies.
FREMONT, CA / ACCESS Newswire / June 19, 2025 / CliniOps, Inc., a leading provider of digital technology solutions for clinical trials, announced today that Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, has selected CliniOps as the technology partner to support multiple Post-Marketing Surveillance (PMS) studies for Valneva's IXCHIQ® vaccine against the chikungunya virus (CHIKV).
Valneva Selects CliniOps as the Technology Partner for multiple PMS studies to Support the IXCHIQ® Chikungunya Vaccination Program
As part of the continued evaluation of IXCHIQ®'s safety and efficacy in real-world settings, Valneva will conduct several PMS studies.
Pregnancy Surveillance Study: This prospective observational study aims to evaluate vaccine safety, through monitoring approximately 100 pregnant women exposed to IXCHIQ®.
Safety Cohort Study: Designed to estimate the incidence of medically attended Adverse Events of Special Interest (AESIs), this study will enroll 5,000 adolescent and adult participants across 10 municipalities. It will also monitor for laboratory-confirmed CHIKV infection post-vaccination.
Serosurvey Study: Aimed at assessing pre-exposure CHIKV prevalence in adolescents and adults, this study will include 5,000 participants, with point-of-care blood sample collection integrated into the workflow.
CliniOps' Unified Platform, featuring electronic data capture (EDC), eConsent, and ePRO, will enable participant enrollment, digital consent, data collection, and remote or in-person follow-up, ensuring flexibility and compliance across municipalities in urban and remote settings. The solution includes robust offline capabilities via mobile tablets, allowing site staff to reliably collect and synchronize data in areas with limited connectivity. CliniOps will work closely with P-95, Valneva's CRO partner, and also with Instituto Butantan, one of the world's largest biomedical research centers based in Sao Paulo, Brazil, to provide comprehensive training and ongoing support.
"These post-marketing studies support our ongoing efforts to further explore the real-world safety and effectiveness of IXCHIQ® and fulfill post-marketing surveillance requirements in populations exposed to CHIKV-endemic areas," said Dr. Juan Carlos Jaramillo, Chief Medical Officer at Valneva. "Our collaboration with CliniOps aligns with Valneva's strategic focus on driving more efficient, cost-effective, and high-quality clinical processes through the use of innovative technologies."
"This collaboration with Valneva highlights the growing global demand for agile, tech-enabled clinical trials," said Avik Pal, CEO, CliniOps. "We are certainly honored to bring our technology to bear on a public health initiative of this magnitude, supporting real-world data collection and post-approval monitoring for a vaccine with significant global impact."
Chikungunya virus (CHIKV) is spread to humans by the bite of an infected mosquito (Aedes aegypti and Aedes albopictus). Several significant CHIKV outbreaks are ongoing globally, including in Brazil where 71,578 CHIKV cases had been reported as of March 2025, the highest number globally for the year.
About Valneva
Valneva is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. https://valneva.com
About CliniOps
CliniOps is a leading technology and data science company for the life sciences industry. CliniOps offers a Unified Platform Technology with multiple patents, for Reimagined Clinical Trials, with the ability to also support Hybrid and Decentralized Trials (Hybrid DCT). CliniOps is committed to making clinical trials accessible, inclusive, faster and efficient, by leveraging powerful technology with rich data-driven solution offerings. https://www.cliniops.com/
Contact Information
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SOURCE: CliniOps, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/valneva-selects-cliniops-as-the-technology-partner-for-multiple-post-1011366
